Principles on Development of Combination Ophthalmic Solutions for Glaucoma — PMDA Early Consideration Summary
Quality of Fecal Microbiota Transplantation (FMT) Products at the Initial Development Stage — PMDA Early Consideration Summary
Points to Consider in the Clinical Development of In Vivo Diagnostics — PMDA Early Consideration Summary
Points to Consider in the Clinical Development of Radiopharmaceuticals for Positron Emission Tomography Targeting Prostate Specific Membrane Antigen (PSMA PET) — PMDA Early Consideration Summary
Principles for the Evaluation of Vaccines Against the Novel Coronavirus SARS-CoV-2 (Appendix 5) Quality data required for the approval review of changing a strain in the vaccine for which the manufacturing process is well established — PMDA Early Consideration Summary
Points to consider in the clinical development of drugs for transthyretin amyloid cardiomyopathy — PMDA Early Consideration Summary
Points to Consider in Developing Drugs for Pediatric Inflammatory Bowel Disease — PMDA Early Consideration Summary
Points to Consider for the Efficacy Evaluation of Drugs for IgA Nephropathy — PMDA Early Consideration Summary
Points to Consider for the Design of Clinical Trials to Assess the Effects of Psychotropic Drugs on Driving Performance — PMDA Early Consideration Summary
Points to Consider for the Development of Companion Diagnostics Developed in Parallel with Anti-cancer Drugs — PMDA Early Consideration Summary